Abiomed Impella Manuel D'utilisation page 9

TRANSPORT WITHIN THE HOSPITAL
Patients supported with the Impella System may require transport within
the hospital for various reasons. Transport can be safe and simple for
patients supported with Impella Catheters.
Considerations for transport within the hospital:
• The AIC and Impella Catheters are designed to operate on battery
power for at least 1 hour.
• Confirm that the battery capacity displayed on the controller is 100%.
• If transport time might be longer than 1 hour, bring an extension cord
or confirm that you will be able to connect the controller to AC power
once you arrive at your destination.
• When rolling the AIC cart across a threshold, firmly grasp the cart
handle and pull it over the threshold.
• Pay close attention to all system components and connections when
rolling the AIC cart over thresholds and through elevator doors.
• Do not stress the connector cable from the controller to the Impella
Catheter.
TRANSPORT BETWEEN HOSPITALS
During transport, the Automated Impella Controller (AIC) may
be exposed to stronger electromagnetic disturbance than during
in-hospital use. Strong electromagnetic disturbance may cause
the AIC to display soft button menu selections that were not
selected by the user. Operators should be aware that, under
these conditions, the operating parameters are not affected.
No user intervention is required. Monitor Impella Catheter flow
and patient hemodynamics to confirm normal operation. The
condition will resolve itself once the AIC is no longer exposed to
the disturbance.
Guidelines for Patient Transport
The AIC is qualified for safe use by healthcare professionals to facilitate
the transport of patients supported by the Impella System from one
medical facility to another. To use the system during transport you must
understand and follow the instructions in this manual. The transport team
should include person(s) fully trained in the use of the AIC and the Impella
Catheter.
Patients are placed on the AIC for circulatory support for periods compliant
with the intended use duration of the Impella Catheter. If, during this time,
a patient requires additional resources and specialized teams at another
location (e.g., a larger facility such as a transplant center), the patient may
be transferred safely to such a location using the AIC.
Maintaining optimal patient hemodynamic status and correct Impella
Catheter position are two key factors in managing patients supported with
the Impella System during transport. Steps should be taken to eliminate
or minimize any aspect of the transport that might adversely affect these
factors.
The AIC is designed to operate for 60 minutes on battery power. Transport
teams should take this into consideration when planning the transport. If
the total transport time is expected to include more than 60 minutes during
which the system will be disconnected from AC power, arrangements
should be made to use a vehicle with a built-in DC to AC power inverter.
Automated Impella Controller
Important Transport Considerations
1.
Planning is critical to success. Abiomed representatives can help
with planning for transport. They can be contacted 24 hours a day
at the Abiomed 24hr hot-line (see back cover).
2.
The Automated Impella Controller should be fully charged prior to
transport. Keep the Automated Impella Controller connected to AC
power (or an AC inverter) whenever possible.
3.
Do not stress the connector cable from the controller to the Impella
Catheter. Such tension could move the catheter out of correct
position and compromise patient circulatory support.
4.
Carefully monitor purge pressures during changes in altitude.
5. The controller should be positioned to allow easy access to the
display screen and soft buttons to view alarms and make any
necessary changes.
6. Maintain ACTs between 160 and 180 seconds or at the level
recommended by the physician responsible for the patient.
PREPARING FOR USE IN FLIGHT−ENABLE FLIGHT MODE
Flight Mode is available in the software for air transport. When active,
Flight Mode disables the purge cassette RFID transmitter so the controller
cannot detect the purge cassette. If any purge system alarms are triggered
during transport, the transport team should inform the managing hospital
upon arrival.
When preparing to use the system in-flight, select > Menu > Settings/
Service > Enable Flight Mode. When Flight Mode is active, a white
alarm appears on screen (see Figure below). During air transport, a
grounding cable is needed to connect the controller to ground. The
grounding cable is provided by the hospital.
Once transport is complete, select > Menu > Settings/Service > Disable
Flight Mode.
TO ENABLE FLIGHT MODE
Select: > Menu > Settings/Service > Enable Flight Mode.
A white alarm appears at the top of the screen:
You are instructed to connect the controller to a ground. Upon arrival, you
are instructed to disable Flight Mode.
Note: the AIC cannot detect the purge cassette while in Flight mode.
Therefore, there are special purge system alarms that direct you to inform
the team receiving the patient. You are advised to have the team address
operations when Flight mode is disabled.
TO DISABLE FLIGHT MODE
Select: > Menu > Settings/Service > Disable Flight Mode.
The updated software permits the user to switch off the Purge Cassette
Detection (RF-ID) to enable safe air transport.
DEFIBRILLATION
During defibrillation, do NOT touch the Impella Catheter,
cables, or Automated Impella Controller.
If emergency defibrillation is required during support with the Impella
System, universal safety precautions should be followed. To avoid the risk
of electrical shock, caregivers should use caution during defibrillation to
ensure they do not touch the Impella Catheter, cables, or controller.
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